NCT06720896

A Phase 2, Controlled, Double Blind, Randomized and Multicenter Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis.

Vision and Inflammation Study Testing Anti-acarid Therapeutics (VISTA-1): A Phase 2, Controlled, Double Blind, Randomized and Multicenter Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Aperta Biosciences, LLC · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to establish the clinical efficacy of APT-001 topical therapy 1.8% in patients with blepharitis as compared to its vehicle control, and to establish that the therapeutic is safe and generally well tolerated by patients.

Detailed description

This Phase 2 study is a randomized, controlled, double-blind trial to compare the safety and efficacy of APT-001 1.8% to vehicle control for the treatment of blepharitis. The primary objective of the study is to compare the safety and efficacy of APT-001 compared to its vehicle from Day 1 to Day 43 in patients with blepharitis. The primary efficacy endpoint will be cure based upon collarettes. Safety will be determined by assessing adverse effects related to the treatment.

Conditions

• Blepharitis

Interventions

Type	Name	Description
DRUG	APT-001 topical ophthalmic ointment (spinosad)	APT-001 topical ophthalmic ointment, administered once daily
DRUG	Vehicle control for APT-001 topical ophthalmic ointment	Vehicle control for APT-001 topical ophthalmic ointment, administered once daily

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-12-06
• Last updated: 2025-12-16

Locations

2 sites across 1 country: Guatemala